NDC 0069-3080

ZITHROMAX

Azithromycin Dihydrate

ZITHROMAX is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Azithromycin Dihydrate.

Product ID0069-3080_209f8a1f-6366-4390-96d1-e35b231a0749
NDC0069-3080
Product TypeHuman Prescription Drug
Proprietary NameZITHROMAX
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1996-06-12
Marketing CategoryNDA / NDA
Application NumberNDA050730
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength600 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-3080-30

30 TABLET, FILM COATED in 1 BOTTLE (0069-3080-30)
Marketing Start Date1996-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-3080-30 [00069308030]

ZITHROMAX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050730
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-06-12
Marketing End Date2018-09-30

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE600 mg/1

OpenFDA Data

SPL SET ID:b749df83-49b0-433e-8a62-589a048dd716
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211511
  • 861416
  • 861417
  • 204844
    • UPC Code
  • 0300693080304

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

    NDC Crossover Matching brand name "ZITHROMAX" or generic name "Azithromycin Dihydrate"

    NDCBrand NameGeneric Name
    0069-0400Zithromaxazithromycin dihydrate
    0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATE
    0069-3060Zithromaxazithromycin dihydrate
    0069-3070Zithromaxazithromycin dihydrate
    0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATE
    0069-3110Zithromaxazithromycin dihydrate
    70518-0249ZithromaxZithromax
    70518-0336ZithromaxZithromax
    70518-0505ZithromaxZithromax
    0069-3120ZithromaxZithromax
    0069-3130ZithromaxZithromax
    0069-3140ZithromaxZithromax
    0069-3150ZithromaxZithromax
    50090-0603ZithromaxZithromax
    55154-2713ZithromaxZithromax
    61919-555ZITHROMAXZITHROMAX
    0069-4061ZithromaxZithromax
    0069-9500ZithromaxZithromax

    Trademark Results [ZITHROMAX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZITHROMAX
    ZITHROMAX
    74034510 1702392 Live/Registered
    PFIZER INC.
    1990-03-05
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